Cleared Special

World Liner

K243162 · Signature Orthopaedics Pty, Ltd. · Orthopedic

Nov 2024

Decision

56d

Days

Class 2

Risk

About This 510(k) Submission

K243162 is an FDA 510(k) clearance for the World Liner, a Prosthesis, Hip, Semi-constrained, Uncemented, Metal / Polymer, Non-porous, Calcium Phosphate (Class II — Special Controls, product code MEH), submitted by Signature Orthopaedics Pty, Ltd. (Lane Cove West, AU). The FDA issued a Cleared decision on November 25, 2024, 56 days after receiving the submission on September 30, 2024. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3353.

Submission Details

510(k) Number	K243162 FDA.gov
FDA Decision	Cleared SESE
Date Received	September 30, 2024
Decision Date	November 25, 2024
Days to Decision	56 days
Submission Type	Special
Review Panel	Orthopedic (OR)
Summary	Summary PDF

Device Classification

Product Code	MEH — Prosthesis, Hip, Semi-constrained, Uncemented, Metal / Polymer, Non-porous, Calcium Phosphate
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 888.3353